Laryngoscope with means to restrict re-use of blades

ABSTRACT

The invention relates to medical devices for carrying out internal examination, such as laryngoscopes ( 1 ). In particular, it relates to laryngoscopes ( 1 ) or devices which have a disposable blade ( 3 ) and provides means for restricting the re-use of blades ( 3 ) which have been used previously.

The present invention relates to medical devices for carrying outinternal examination and relates particularly to laryngoscopes to assistintubation of a tracheal tube that have disposable sections.

Insertion of a tracheal tube is an important procedure in providing anairway to an anaesthetist prior to a surgical operation. Tracheal tubesalso often need to be inserted in an emergency situation into the airwayof an unconscious patient by paramedics or doctors. Insertion of atracheal tube requires significant skill, and laryngoscopes aregenerally used to assist the insertion of the tube by restraining thepatient's tongue and allowing a clear view of the larynx and theentrance to the trachea. Considerable skill and care is required incarrying out this procedure in order to avoid damage to the patient'steeth and soft tissue of the throat.

Often problems occur when a practitioner is attempting to intubate apatient using a laryngoscope as it is often difficult for thepractitioner to see what is going on.

Figures show that in approximately 12% of cases trauma occurs duringintubation (which affects a large number of people when you considerthere are over 12 million intubations carried out annually).

A UK wide study found 50% of apparently clean laryngoscope handleswaiting for re-use to be contaminated with blood from previousprocedures. This is due to design flaws in the traditional laryngoscopeand ineffective cleaning practice within hospitals. Where disposablesingle use surgical instruments have already been introduced, 12% ofhospitals are actually re-using them due to the high cost ofreplacement. Making the situation worse, these elements are often nevercleaned due to the assumption of single use sterility.

Obviously in order to use a laryngoscope on a patient, it is importantto know that the laryngoscope is cleaned sufficiently and there is norisk of cross contamination between patients. There is evidence to showthat standard cleaning procedures are not always fully effective atremoving contaminants such as bacteria from the laryngoscope (J R Hall.‘Blood contamination of equipment . . . ’ Anaesthesia and Analgesia.1994; 78:1136-9 M D Ester, L C Baines, D J Wilkinson & R M Langford.‘Decontamination of Laryngoscopes: a survey of national practice.’Anaesthesia, 1999, 54).

Typically, in order to clean a laryngoscope, the blade is soaked andautoclaved. The handle can undergo a similar procedure or can simply bewiped down as it does not make contact with the patient as the bladedoes. The cleaning takes a significant amount of time, which means thatit is necessary to have a number of handles and blades in rotation toensure that there are always clean laryngoscopes available if required.This results in a time consuming and costly procedure needing to be putin place.

In order to try and overcome the problems associated with laryngoscopedisposable blades have been suggested for use. Unfortunately, it iscommon in practice that the blades are still used multiple times beforebeing discarded. Flexible protective sheaths can also be used which slipover a standard laryngoscope blade to act as a guard. While useful, itis optional to a user whether the sheath is used or not. For the user,existing blades perform better without the sheath, which distorts lightoutput and, as a result, existing sheaths are rarely used.

The present invention attempts to improve upon the prior art.

Throughout this Application the term blade should be read in a broadsense to cover not only laryngoscope blades but also to cover speculumsor elements that are inserted into body cavities.

According to a first aspect of the present invention, there is provideda medical device comprising a body portion and a blade portion, whereinthe blade portion is separable from the body portion characterised bythe medical device being provided with spoiling means for indicating ifa particular blade portion has already been attached to the body portionpreviously.

Optionally, the spoiling means will prevent reattachment of a blade thathas already been attached to a body portion previously.

Preferably, the spoiling means comprises transmitting and receivingmeans in the body, which send and receive signals respectively withreceiving and transmitting means in the blade.

Preferably the receiving means in the body can determine from thetransmitting means in the blade, if the blade has previously beenbrought into close proximity of a body.

Preferably the transmitting means is a radio frequency transmitter.

Preferably the receiving means is a radio frequency receiver.

Optionally, the receiving means in the body will count the number ofblades it contacts in its life.

Optionally, the spoiling means comprises a device for trippingelectrical contacts to prevent their continued use.

Optionally the spoiling means comprises elements that cause a physicalchange if a particular blade portion has already been attached to thebody portion previously.

Alternatively, the spoiling means comprises locking elements that breakoff when the blade and body are separated.

Preferably the locking elements comprise a male protrusion and a femaleingression, one of which is provided on the blade and one of which isprovided on the body.

Preferably the male protrusion is provided with a weakened section.

Preferably the female ingression is provided with a weakened section.

In order to provide a better understanding of the present invention,embodiments will now be described by way of example only, and withreference to the following Figures, in which:

FIG. 1 shows a cross section view of a laryngoscope according to a firstaspect of the present invention.

FIG. 2 shows a cross section view of a laryngoscope according to asecond aspect of the present invention.

In the preferred embodiment of the present invention, the medical deviceis a laryngoscope that can be used for intubation of a tracheal tube.

According to the present invention, there is a provided a laryngoscope 1which has a disposable blade 3. The blade 3 is the section that comesinto contact with the patient during examination. Therefore, after usethe blade 3 can be disposed of and the remaining parts of thelaryngoscope 1 re-used.

One of the benefits of the disposability of the blade 3 is that therewill be no cross-contamination to patients, and no lengthy cleaningprocedures are required.

However, to ensure that a blade 3 is not reused, a spoiling mechanism isincorporated into the laryngoscope laryngoscope 1.

In one embodiment, a mother chip 4 is provided in the body 2 of thelaryngoscope 1. A corresponding radio frequency tag 5 that can berecognised by the mother chip 4 is provided in the disposable blade 3.The radio frequency tag 5 is provided with a serial number and eachradio frequency tag 5 has a unique serial number. When the radiofrequency tag 5 and the mother chip 4 are brought into close contacti.e. by the blade 3 being attached to the body section 2, the motherchip 4 can read the serial number. If the mother chip recognises theserial number from a previous occasion this will be indicated to theuser.

Alternatively, the radio frequency tag does not have a serial number,but the mother chip electronically marks the radio frequency tag, sothat it can be recognised as having previously being in contact withanother body. This is the preferred embodiment.

In the preferred embodiment, the body 2 is provided with a monitor 6. Ifthe mother chip 4 recognises a serial number, or any other electronicsignal on a radio frequency tag 5 of a blade that is being attached, acomputer program will be in place to display a message on a monitorwhich is attached to the body 2 informing the user. The mother chip 4will typically be able to both read the blade chip and write on it. Thiswould allow a blade chip to be electronically written on in a mannerthat means it would be recognised by any body section that it isattached to. This is the preferred embodiment as it ensures that inemergencies for example when a paramedic is called to a scene with asignificant number of casualties, a blade 3 can be re-used if absolutelynecessary. It would also allow the storage of the date, time, patientdetails and other information, if required. An alternative to the radiofrequency messaging described above would be to use a mother chip 4 athat is an optical reader. There would be a mechanism for physicallymarking a blade 3 that has previously been used, and this physical markwould be recognised by the mother chip 4 a. The physical Marks may besurface scoring, discolouring, exposure to light or faint fracturepoints/lines designed to appear after pressure has been applied duringuse.

The benefit of the abovementioned options is that the mother chip 4 or 4a could be programmed to allow a certain number of re-uses which may bewithin a defined period, or allow a manual override in emergencysituations.

Alternatively, the spoiling mechanism can take the form of a breaking ofelectrical connections when the blade 3 and body 2 are parted, such thatif the same blade 3 and body 2 are reconnected, no power is provided toanything inserted into the core 6 of the blade 3. A further alternativeis that the blade 3 may comprise protrusions which are able to fix intoingressions in the body 2 of the laryngoscope 1, such that theprotrusions break off when the blade 3 is removed from the body 2, suchthat the blade 3 cannot then be reused. These alternatives may be moreuseful in non-emergency areas such as operating theatres for routinesurgery where the need to re-use a blade 3 in extreme circumstances isless likely to occur.

It can be seen that the current invention has a number of benefits overthe prior art and a number of possible uses. Although the examples aboverelate to a laryngoscope, it can be seen that the concept can beextended to other medical and veterinary devices and still stay withinthe scope of the present invention. The fact that the blade is fullydisposable is of great importance, as it means that practitioners arerequired to change blades and the product is both simple to use andcheap to manufacture.

It will be appreciated by persons skilled in the art that the aboveembodiment has been described by way of example only, and not in anylimiting sense, and that various alterations and modifications arepossible without departure from the scope of the invention as defined bythe appended Claims.

1. A medical device comprising a body portion and a blade portion,wherein the blade portion is separable from the body portion,characterised by the medical device being provided with a spoiling meansfor indicating if a particular blade portion has already been attachedto a body portion previously.
 2. A medical device as in claim 1, whereinthe spoiling means will prevent reattachment of a blade that has alreadybeen attached to a body portion previously.
 3. A medical device as inclaim 1, wherein the spoiling means will alert a user to a blade thathas already been attached to a body portion previously.
 4. A medicaldevice as in claims 1 to 3, wherein the spoiling means comprises atransmitting means and a receiving means in the body, which send andreceive signals respectively with a receiving and transmitting means inthe blade.
 5. A medical device as in claim 4, wherein the receivingmeans in the body can determine from the transmitting means in theblade, if the blade has previously been brought into close proximity ofa body portion previously.
 6. A medical device as in claim 4 or 5,wherein the transmitting means is a radio frequency transmitter.
 7. Amedical device as in claims 4 to 6, wherein the receiving means is aradio frequency receiver.
 8. A medical device as in claims 4 to 7,wherein the receiving means in the body will count the number of bladesit contacts with.
 9. A medical device as in claims 1 to 8, wherein thespoiling means comprises a device for tripping electrical contacts toprevent their continued use.
 10. A medical device as in claims 1 to 9,wherein the spoiling means comprises elements that cause a physicalchange if a particular blade portion has already been attached to thebody portion previously.
 11. A medical device as in claim 10, whereinthe spoiling means comprises locking elements that break off when theblade and body are separated.
 12. A medical device as in claim 11,wherein the locking elements comprise a male protrusion and a femaleingression, one of which is provided on the blade and one of which isprovided on the body.
 13. A medical device as in claim 12, wherein themale protrusion is provided with a weakened section.
 14. A medicaldevice as in claim 12, wherein the female ingression is provided with aweakened section.